Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors

Completed

• Conditions: Cognition; Breast Cancer; Cognitive Impairment
• Interventions: Other: no intervention

• Registration Number: NCT02591316
• Lead Sponsor: Texas State University, San Marcos

Brief Summary

The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

Detailed Description

The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.

The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
• age-matched controls must have no previous cancer diagnosis
• Female
• no history of stroke, heart attack or transient ischemic attack
• not currently pregnant; can speak, read, and write English
• can attend all testing sessions
• not blind or legally blind; nonsmoker
• no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).

Exclusion Criteria

• male
• < 30 or > 70 years of age
• breast cancer survivor > 60 months from last treatment or currently undergoing primary treatment
• breast cancer survivor never treated with chemotherapy and/or radiation
• previous cancer diagnosis other than breast cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer survivor	no intervention	Inclusion criteria: Female breast cancer survivors (30-70yrs of age) that have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
Control	no intervention	Females (30-70yrs of age) with no previous cancer diagnosis.

Primary Outcome Measures

Name	Time	Method
Cognition	Baseline	A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery

Secondary Outcome Measures

Name	Time	Method
Body Composition (objectively measured)	Baseline	Body composition will be evaluated by BOD POD assessment
Physical Activity	Baseline	Physical activity will be measured by a waist-worn accelerometer
Diet Quality	Baseline	Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire
Inflammatory Markers	Baseline	A fasted blood sample will be collected for measurement of inflammatory markers

Trial Locations

Locations (1)

Texas State University; 🇺🇸 San Marcos, Texas, United States